Date

2017-04-06

Protocol

Protocol changed

Item Changed

Exclusion criteria

Previous Version

Stage I a. Alcohol consumption > 20 g/day, patients with Alcoholic Liver Disease (ALD), patients with cirrhosis and abnormal baseline liver function tests. b. Patients with raised baseline serum creatinine level. c. Patients on insulin therapy at baseline. d. Lactation, pregnancy or unwillingness to use an effective form of birth control for women of child bearing years Stage II a. Alcohol consumption >20 g/day, patients with Alcoholic Liver Disease (ALD), b. Patients with cirrhosis and abnormal baseline liver, renal function tests or blood counts. c. Patient with any chronic illness. d.Patient on any long term medication including any nutritional supplements. e.Lactation, pregnancy or unwillingness to use an effective form of birth control for women of child bearing years

Next Version

1. Alcohol consumption >20 g/day 2. Diagnosed Alcoholic Liver Disease (ALD), 3. Cirrhosis 4. Abnormal baseline liver, renal function tests or other haematological parameters. 5. Any chronic illness. 6. Any long term medication including any nutritional supplements. 7. Lactation, pregnancy or unwillingness to use an effective form of birth control for women of child bearing years